REDUCING THE PAPER CLUTTER OF THE TMF FRAMEWORK FOR THE FRAMEWORK - - PDF document
5/21/2012 Mulcahy_CBI_Reducing Clutter and Framework_May2012 1 REDUCING THE PAPER CLUTTER OF THE TMF FRAMEWORK FOR THE FRAMEWORK FOR THE DESTRUCTION OF PAPER Lisa Mulcahy Mulcahy Consulting, LLC So Why is There Sooooooo Much Paper? 2
1 Mulcahy_CBI_Reducing Clutter and Framework_May2012
2
3
Actually paper isn’t required. Nowhere is it stated that wet-ink signature must be
Signature is required on the following TMF content per ICH
Protocol/Amendments signature page – Sponsor Protocol/Amendment signature page - PI/Institution Signed agreements between Sponsor and Sponsor delegate,
Si d t b t PI/I tit ti d S Signed agreements between PI/Institution and Sponsor
Signed agreements between PI/Institution and regulatory
authority, where applicable (ex Form FDA 1572)
Signed completed CRF forms, including any changes)
4
5
No additional authentication other than text within No additional authentication other than text within
Capture the approval of the document in a
This content will typically be those documents
6
Incorporate the use of electronic and digital
Digital signatures using one of the complex
Authenticated Digital Signatures out to PI level
Digitally sign the protocol signature page and Form
FDA1572
7
Eliminate the collection of paper documentation Portals for sending and receiving electronic Portals for sending and receiving electronic
electronic acknowledgements/audit trails
Assignment of where ‘original’ wet-ink is retained
Form FDA 1572 – original at site, electronic copy to
Consider TMF documents in respect of the data
8
Within the Drug Information Association’s
The initial scope of this effort is focused on
9
Documentation Documentation processes have changed from creating and managing paper documents into producing and managing d t i This conversion process creates redundancy and duplication in the management of documentation in support of the b i The trend is that the remaining paper documents are scanned into a digital format and uploaded into an ECMS documents in electronic formats. business process
10
Destruction of the scanned paper document
11
Intention of this framework
If the banking and
12
Voluntary contributions of the diverse special
13
14
15
The framework is: Non-binding in accordance with the DIA’s
A reference for the industry and should not be
Not endorsing or requiring any specific
16
Technology – Specific requirements and capabilities
Quality – Validation of capture process and scan
Records Management – Policies, procedures and
Regulatory – Established health authority laws &
Legal – Laws of evidence
17
Term
Term Certified Copy
Alternate Name(s) Attested copy, Exemplified copy, Verified copy, Validated copy Definition A Certified Copy is a copy of original information that has been verified through a validated process, as an exact copy having all of the same attributes and information as the original.
Black’s Legal Dictionary A duplicate of an original (usually official) document, certified as an exact reproduction usually by the
ARMA North American Legislation
signature, as an exact copy having all of the same attributes and information as the original”. FDA's Guidance for Industry Computerized Systems Used in Clinical Investigations (May 2007)
matrix or by means of photography including enlargements and miniatures or by mechanical or
Alternate
Definition –
matrix, or by means of photography, including enlargements and miniatures, or by mechanical or electronic re-recording, or by chemical reproduction, or by other equivalent techniques which accurately reproduces the original”.
EU/MS Legislation "Originals or copies certified after verification as being accurate copies"
Harmonized Guidelines
complete) copy having all of the same attributes and information as the original. The copy may be verified by dated signature or by a validated electronic process”
to preserve the information in the original. NOTE: an eCertified copy of an eSource document can also serve as a source document”. CDISC Clinical Research Glossary Version 8.0, (Dec. 2009) Japanese Legislation Although the term of “duplicate” is not defined under the Japanese legislation, the Legal Terminology Dictionary (9th Edition) is stating as follows with respect to “duplicate”: If a person prepares a document having the identical contents as the authenticated copy in addition to the authenticated copy in order to use it for purposes other than its primary purpose the document is
Other legal
the authenticated copy in order to use it for purposes other than its primary purpose, the document is called a “duplicate.” We could not find the definition of the term “certified copy” neither in the Japanese legislation nor the Legal Terminology Dictionary (9th edition). We could not find the definition of the term “record copy” neither in the Japanese legislation nor the Legal Terminology Dictionary (9th edition). “Authenticated copy” is one kind of a copy and means a copy which is prepared based on the original by an authorized person and which has the same effect as the original externally. Hiroshi Kaneko et al., horitsugaku-sho-jiten [The Dictionary of Law] (4th edition, comprehensively revised)(2008) at 320.
18
Overall Process Five sub-processes (note off-page (yellow)
Includes potential collaboration with external
Green boxes show where parameters have been
19
Hi h l l High-level Paper Scanning & Destruction Process Company Support and Governance Pilot / Proof of Concept Scanning of Paper - Production Paper Retention Management In-progress Paper Destruction
20
Critical steps to acceptance Adaptation of process and SOPs to fit company
21
Parameters were created for each of the 5
22
What are the parameters?
Minimum requirements Points to consider Existing rules and guidelines that help justify
Recommendations
23
Scope of the Technology Topic Team: Provide guidance and recommendations to the
Conduct a multi-industry assessment identifying key learning’s and Conduct a multi-industry assessment identifying key learning s and
insights resulting from the process of migrating from a paper environment to an electronic environment and associated ramifications.
Conduct a review of the use of technologies in the pharmaceutical
industry (Pharma, Bio, Device) as it relates to the primary
Etc
24
25
26
Scope of the Quality Topic Team
Provide guidance on a quality focused
27
Q1:There should be a validated quality driven process for document scanning and uploading into an Electronic Content Management System (ECMS) y ( ) Q2:The authenticity of scanned images as certified copies must be established Q3: There must be a documented quality driven process for destruction of paper documents and maintaining certified copies in an ECMS; in compliance with regulations and legal requirements Q4 : All training must be completed and documented Q5: Third party requirements must be specified for when activities Q5: Third party requirements must be specified for when activities transferred to consultants and vendors Q6 : Monitoring of quality must take place Q7: It is critical to perform a risk assessment Q8: The paper destruction process and certification of destruction requirements need to be defined by the company
28
29
Scope of the Records Management Topic
Review industry standards including retention
Establish minimum standards and principles Media format and retention policy to keep electronic methods
current (guidance) (g )
Technology TT will determine the recommended mediums and
methods
Policy for the management of the electronic media to keep current Define electronic copy Document ownership Legal Hold Handling of documents will need to follow regulatory guidelines
30
RM1:Certain characteristics are required for the archiving, retrieval and retention processes involving electronic records. These are necessary to ensure authenticity, reliability, integrity and usability of the electronic records over the long term long-term RM2: There are specific requirements for retaining both wet ink and electronic
required by regulations and when procedures may suffice RM3: A timeline for the discarding of the paper originals is dependent on following the appropriate procedures RM4: Take risk parameters into account before deciding on a procedure to destroy paper RM5: Access to electronic records must be facilitated continuously across time RM6: There are essential business requirements that must be considered in creating a viable electronic archiving program RM7: The risks associated with the reliability of electronically converted and stored documents must be assessed (as compared to paper) RM8: There are numerous stakeholders surrounding the management of content. RM9: Some document types must be identified as “Protected” in order to prevent the destruction of those paper documents
31
32
Scope of the Regulatory Topic Team Ensure all topic teams’ research is aligned with
Interpret applicable portions of the regulations/guidelines to determine if they
support topic teams’ deliverables
Identify the lack of clarity in regulations/guidelines, and provide recommendations
to address gaps that prevent the industry from completely adopting the eTMF paper destruction framework, thus preventing the destruction of paper
Liaise with regulatory authorities throughout the development of the eTMF paper
destruction framework to understand the practical and technical issues identified by authorities that must be addressed within the framework by authorities that must be addressed within the framework
Provide specific regulatory guidelines with
Address the issue of eSignatures
33
R1: For each record required to be maintained under predicate rules, you must determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities R2 Create a compan ide in entor of o r tools and assess hether the perform R2: Create a company-wide inventory of your tools and assess whether they perform quality or business critical and determine if validation is necessary R3: Ensure that computerized technologies meet, at minimum, applicable current requirements R4: Ensure the organization’s selected technology provides an audit trail for signatures that captures date, time, or the sequence of events in a particular instance. Sponsors should ensure appropriate use of electronic vs. digital signatures R5: When used, time stamps must be implemented with a clear under-standing of the time zone applied R6: Electronic Signatures R7: An electronic certificate of authority signed by a credible and verifiable notary representative is required for each notarized electronic document R8: Documented rules governing the conduct of parties using electronic signatures must be available R9: Organization must adopt/create and train all employees on a corporate level policy detailing the use of electronic signatures. R10: Address the concern for Japanese raised seals
34
35
Scope of the Legal Topic Team The Legal Topic team will define the North The Legal Topic team will define the North
Only a sampling of EU member states will be included in scope.
Precedents and s pporting citations ill be limited to Clinical Trial
Precedents and supporting citations will be limited to Clinical Trial
area and other regulated industries or existing document processing examples where similar approach has been successful, e.g. mortgages, tax filing
Definitions will be limited to those found in the Paper Destruction
Working Group Objectives xls under Legal.
Only a sampling of EU member states will be included in scope. Etc.
36
L1:Once records exist, they may be sought as evidence in government inquiries, civil litigation, or criminal prosecution L2: If a company maintains ECMS and scans documents and certifies them as the a thoritati e so rce disco er of these doc ments “stand on eq al footing ith authoritative source, discovery of these documents “stand on equal footing with discovery of paper documents.” L3: The duty to preserve evidence in support of litigation holds extends to data compilations, computerized data and other electronically recorded information L4: Electronic signatures and records are equivalent to paper signatures and records, and therefore are subject to the same legal scrutiny to determine authenticity L5: A process that accurately reproduces or forms a durable medium for reproducing the
used in the regular course of business [Business As Usual]. L6: Destruction of original paper records should not be prohibited once a complete and t l t i diti i d l i d b di t l th accurate electronic rendition is made unless required by a predicate rule or other applicable legal requirement. L7: Sponsors of a clinical trial must of the essential documents of this clinical trial. Records may be kept on magnetic or other media, thus including electronic document management systems (ECMS). L8: Policies, procedures, and other quality and compliance documentation, including partner agreements, developed or modified to support the paper destruction process should be reviewed in light of applicable legal requirements. The implementation of a paper destruction process may entail the review of documentation beyond records management policies (e.g. vendor oversight SOP).
37
38
M ’11
Mar’11 • Charter drafted Dec’11
Feb ’12
Jun’12
39
40
The framework is a set of guidelines and
It is not an exact answer nor a prescription for
The framework requires careful consideration,
Consider following the steps in the process
41
42
43
Join the team to the update framework due to
Contact Lisa Mulcahy at